United Health Products Submits Response Letter to FDA
United Health Products (OTCPK: UEEC) has provided an update on its FDA Premarket Approval (PMA) application process. The company submitted a Submission Issue Request to the FDA on August 15, responding to questions and outlining its approach to address deficiencies identified in the FDA's June 18 'Deficiencies Letter'. UHP has requested a video conference with the FDA PMA application review team, expected to take place in early September. The FDA's 180-day review period, currently at about 90 days, remains paused during this engagement. CEO Brian Thom expressed anticipation for an interactive discussion with the FDA to clarify necessary actions for a final determination on the PMA application. However, there is no guarantee of approval for the company's PMA application.
United Health Products (OTCPK: UEEC) ha fornito un aggiornamento sul processo di richiesta di approvazione pre-market (PMA) dalla FDA. L'azienda ha inviato un Submission Issue Request alla FDA il 15 agosto, rispondendo a domande e delineando il proprio approccio per affrontare le carenze identificate nella 'Lettera di Deficienze' della FDA del 18 giugno. UHP ha richiesto una videoconferenza con il team di revisione della richiesta PMA della FDA, prevista per inizio settembre. Il periodo di revisione di 180 giorni della FDA, attualmente a circa 90 giorni, rimane sospeso durante questo incontro. Il CEO Brian Thom ha espresso attesa per una discussione interattiva con la FDA per chiarire le azioni necessarie per una decisione finale sulla richiesta PMA. Tuttavia, non c'è alcuna garanzia di approvazione per la richiesta PMA dell'azienda.
United Health Products (OTCPK: UEEC) ha proporcionado una actualización sobre su proceso de solicitud de aprobación previa al mercado (PMA) ante la FDA. La compañía presentó una Solicitud de Problema de Presentación a la FDA el 15 de agosto, respondiendo a preguntas y delineando su enfoque para abordar las deficiencias identificadas en la 'Carta de Deficiencias' de la FDA del 18 de junio. UHP ha solicitado una videoconferencia con el equipo de revisión de solicitudes PMA de la FDA, que se espera tenga lugar a principios de septiembre. El período de revisión de 180 días de la FDA, que actualmente está en alrededor de 90 días, permanece pausado durante este compromiso. El CEO Brian Thom expresó su anticipación por una discusión interactiva con la FDA para aclarar las acciones necesarias para una determinación final sobre la solicitud PMA. Sin embargo, no hay garantía de aprobación para la solicitud PMA de la empresa.
United Health Products (OTCPK: UEEC)는 FDA 사전 시장 승인(PMA) 신청 과정에 대한 업데이트를 제공했습니다. 이 회사는 8월 15일에 FDA에 제출 문제 요청을 제출했으며, 이는 질문에 대한 답변과 FDA가 6월 18일에 발송한 '결함 통지서'에서 확인된 결함을 해결하기 위한 접근 방식을 설명했습니다. UHP는 FDA PMA 신청 검토 팀과의 화상 회의를 요청하였으며, 이는 9월 초에 진행될 것으로 예상됩니다. 현재 약 90일인 FDA의 180일 검토 기간은 이번 참여 동안 중단된 상태입니다. CEO Brian Thom은 FDA와의 상호 작용적인 논의에 대한 기대감을 표명하며 PMA 신청에 대한 최종 결정을 위한 필요한 조치를 명확히 하기를 희망했습니다. 그러나 회사의 PMA 신청에 대한 승인 보장은 없습니다.
United Health Products (OTCPK: UEEC) a fourni une mise à jour sur son processus de demande d'approbation préalable à la commercialisation (PMA) auprès de la FDA. L'entreprise a soumis une demande de problème de soumission à la FDA le 15 août, en réponse à des questions et en décrivant son approche pour traiter les lacunes identifiées dans la 'lettre de lacunes' de la FDA du 18 juin. UHP a demandé une visioconférence avec l'équipe de révision des demandes PMA de la FDA, qui devrait avoir lieu début septembre. La période de révision de 180 jours de la FDA, qui est actuellement d'environ 90 jours, reste suspendue durant cet engagement. Le PDG Brian Thom a exprimé son anticipation pour une discussion interactive avec la FDA afin de clarifier les actions nécessaires pour une décision finale sur la demande PMA. Cependant, il n'y a aucune garantie d'approbation pour la demande PMA de l'entreprise.
United Health Products (OTCPK: UEEC) hat ein Update zu seinem Antrag auf FDA-Vorabgenehmigung (PMA) bereitgestellt. Das Unternehmen hat am 15. August einen Submission Issue Request an die FDA eingereicht, um auf Fragen zu antworten und seinen Ansatz zur Behebung der Mängel, die im 'Mängelschreiben' der FDA vom 18. Juni identifiziert wurden, darzulegen. UHP hat eine Videokonferenz mit dem FDA PMA-Antrag-Überprüfungsteam angefragt, die voraussichtlich Anfang September stattfinden wird. Der 180-tägige Überprüfungszeitraum der FDA, der derzeit bei etwa 90 Tagen liegt, bleibt während dieses Engagements pausiert. CEO Brian Thom äußerte die Erwartung einer interaktiven Diskussion mit der FDA, um die notwendigen Schritte zur endgültigen Entscheidung über den PMA-Antrag zu klären. Es gibt jedoch keine Genehmigungsgarantie für den PMA-Antrag des Unternehmens.
- Company proactively responding to FDA's Deficiencies Letter
- Requested video conference with FDA review team for interactive engagement
- Approximately half of the FDA's 180-day review period still remains
- FDA review process paused due to identified deficiencies
- No assurance of PMA application approval
- Potential delays in product approval and market entry
MT. LAUREL, NJ, Aug. 19, 2024 (GLOBE NEWSWIRE) -- United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval (PMA) application process.
Following the company’s March 21 submission of its PMA application and the FDA’s June 18 “Deficiencies Letter” to the company listing certain questions and comments on various elements of the application, on August 15, UHP submitted a Submission Issue Request to the FDA responding to certain questions and detailing its approach to addressing certain identified deficiencies.
The company has requested video conference with the FDA PMA application review team to discuss its responses and proposed solutions to the deficiencies. UHP anticipates the meeting to take place in early September.
UHP’s Chief Executive, Brian Thom, commented: “We look forward to an interactive engagement with the FDA to gain clarity on what actions and information are needed in order to make a final determination on the merits of our PMA application.”
The FDA’s 180-day application review period, of which approximately 90 days have elapsed, will remain paused while the company engages further with the FDA and addresses any remaining deficiencies.
There can be no assurance that the company’s PMA application will be approved.
About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.
For more information on UHP visit the company’s new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
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